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Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR)

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Civil Hospices of Lyon

Status and phase

Unknown
Phase 3

Conditions

Cardiovascular Diseases

Treatments

Device: Percutaneous MitraClip Device Implantation
Other: control

Study type

Interventional

Funder types

Other

Identifiers

NCT01920698
2013-A00464-41 (Other Identifier)
2013.798

Details and patient eligibility

About

The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.

This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).

Enrollment

288 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years old
  • Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume>30 mL/beat or an effective regurgitant orifice>20 mm².
  • New York heart Association Class≥ II.
  • Left ventricular ejection fraction between 15% and 40%
  • Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
  • Optimal standard of care therapy for heart failure according to investigator.
  • Not eligible for a mitral surgery intervention according to the Heart Team.
  • Willingness to participate in the study and signed written informed consent
  • Affiliation to a health insurance system or a similar system

Exclusion criteria

  • Eligible for a mitral surgery intervention according to the Heart Team.
  • Primary mitral regurgitation.
  • Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
  • Cardiac resynchronization therapy within three months prior to randomization.
  • Cardioversion within three months prior to randomization
  • Transcatheter aortic valve implantation within three months prior to randomization
  • Need for any cardiovascular surgery (including registration on cardiac transplant list).
  • Coronary angioplasty within one month prior to randomization.
  • Previous surgical mitral valve repair.
  • Renal replacement therapy.
  • Active infection requiring current antibiotic therapy.
  • Severe hepatic insufficiency.
  • Stroke within three months prior to randomization.
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • Uncontrolled arterial hypertension.
  • Hypersensitivity to nitinol.
  • Participation to another trial.
  • Pregnancy.
  • No affiliation to a health insurance system.
  • Legal protection measure (guardianship or curatorship)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

288 participants in 2 patient groups

MitraClip Device
Experimental group
Description:
Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
Treatment:
Device: Percutaneous MitraClip Device Implantation
Control
Other group
Description:
Patients randomized to the Control group will receive optimal therapy alone
Treatment:
Other: control

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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